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Irreversible Electroporation(IRE) For Unresectable Prostatic Neoplasms (IRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02430649
Recruitment Status : Withdrawn
First Posted : April 30, 2015
Last Update Posted : May 27, 2020
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Prostatic Neoplasms.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: Irreversible electroporation (IRE) Device: NanoKnife Not Applicable

Detailed Description:
By enrolling patients with unresectable Prostatic Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Prostatic Neoplasms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Irreversible Electroporation(IRE) For Unresectable Prostatic Neoplasms: Phase I and Phase II Clinical Trial
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: IRE Group
irreversible electroporation for Unresectable Prostatic Neoplasms
Procedure: Irreversible electroporation (IRE)
Other Name: NanoKnife

Device: NanoKnife
No Intervention: Control
The patients without treatment

Primary Outcome Measures :
  1. Number of participants with Adverse events [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Percentage of lesions that show no sign of recurrence 12 months after IRE [ Time Frame: 12 months ]
  2. Voltage (A minimum and maximum range of voltage for safe and effective IRE) [ Time Frame: 3 months ]
    A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.

  3. Progress free disease (PFS) [ Time Frame: 12 months ]
  4. Overall survival (OS) [ Time Frame: 36 months ]
    Patients will be followed for 36 months after IRE for OS analyzed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Prostatic Neoplasms diagnosed by positive biopsy or non-invasive criteria,
  • Not suitable for surgical resection,
  • Eastern Cooperative Oncology Group (ECOG) score of 0-1,
  • A prothrombin time ratio > 50%,
  • Platelet count > 80x10^9/L,
  • Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
  • Able to comprehend and willing to sign the written informed consent form (ICF),
  • Have a life expectancy of at least 3 months.

Exclusion Criteria:

  • Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
  • Any active implanted device (eg Pacemaker),
  • Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
  • Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
  • Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02430649

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China, Guangdong
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
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Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital
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Responsible Party: Fuda Cancer Hospital, Guangzhou Identifier: NCT02430649    
Other Study ID Numbers: Prostatic Neoplasms-IRE-01
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Keywords provided by Fuda Cancer Hospital, Guangzhou:
irreversible electroporation
Unresectable Prostatic Neoplasms
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases